1. Field of the Invention
The present invention is intended to disclose a device for the height-adjustable fixing and support of internal anatomical organs, by means of which it is possible to effect in a very simple manner the securing of internal anatomical structures and organs when they are positioned in the desired position by the surgeon, additionally having properties of adjustment in height as required.
As is already known, in operating practice there are situations in which the surgeon wishes to position and ensure the securing of internal anatomical organs at a certain height with respect to specific references of the human body, for the purpose of completing the operation carried out and/or in order to perform organic functions, making good certain bodily functions or assisting them.
One of the fields of more specific application of the device which is the subject of the present invention will be that of urinary tract surgery, in particular urinary tract surgery concerned with the correction of urinary incontinence.
2. Description of the Related Art
In particular, the object of the present invention is to ensure a complete cure for severe urinary incontinence in women, which has been repeatedly operated on without success with the conventional surgical techniques, since at present no method has been described which ensures a cure for this.
The problem of urinary incontinence is one of the most widespread nowadays, the attempt to propose effective remedies in order to try to reduce its effects being very costly. For example, in North America, according to CARL G. KLUTKE of the Urology Department of the University of Washington, incontinence affects more than twenty million people and more than half the admissions to chronic centres and an annual expense of a billion dollars for absorbent devices and others are attributed to it.
Moreover, the said problem is increasing with the expectation of greater longevity of the population. Increasing costs are assumed which become insupportable for the various health administrations of each country.
In particular, the treatment of female urinary stress incontinence continues to be a formidable task for the health community, according to what is stated by C. G.KLUTKE in his publication "Female stress incontinence in the 90's". Considerable efforts have been made, but it is necessary to understand the problem better and achieve a more effective treatment. The surgical treatment of this ailment will continue to be an important feature of urology. The enthusiasm for new innovative surgical approaches should be weighed against objective evidence of results and with a clear understanding of the morbidity involved.
Multiple vaginal deliveries, removal of the uterus, and menopausal vaginal changes are factors which contribute to prolapse and to urinary stress incontinence in women.
The involuntary loss of urine may occur by means of two mechanisms which, for the moment, require different surgical techniques for their correction. The most common is the descent or dropping of the neck of the urinary bladder and of the urethra (hypermobile urethra).
The other is due to the fact that the urethra has lost its closure capacity (deficiency of the internal sphincter). In men, incontinence is produced by lesion of the external sphincter in the course of operations on the prostate.
More than a hundred surgical techniques for the correction of incontinence have been described. The large number of procedures proposed demonstrates that the problem persists. The percentage of failures is very high and increases with the passage of time, as attested by the most recent publication of Stefan Conrad of the University of Hamburg (J. Urol. No. 1 32-37, 1998), who presents the long term results (5 years) of the Stamey suspension intervention, which is the treatment of choice for stress incontinence in women, and in which he emphasises that the failure rate is 50% out of a total of 130 patients evaluated.
When the neck of the bladder and the urethra are found to have descended, the object of surgery is to return them to their original anatomical position; in order to achieve this, it is necessary to displace these structures upwards and forwards, and they have to be raised behind the pubis.
The treatment of defective functioning of the sphincter of the urethra causing urinary incontinence is linked to achieving greater urethral resistance, which is obtained either by means of a sling suspending the neck of the bladder, or by the reconstruction of the said neck, or also by means of periurethral injections of polytetrafluorethylene or by means of an artificial urinary sphincter.
The procedure based on the sling suspending the neck of the bladder is relatively simple and offers certain advantages over the remaining procedures. Many procedures based on the technique of the suspension sling are known and have been described since the beginning of this century.
The ALDRIDGE technique is classic and has remained for many years the most frequently employed. Another similar technique was described by MOIR and in 1984 POLLACK and his associates described the use of tendons and aponeurosis as a sling for suspending the neck of the bladder when connecting it with the COOPER ligament.
Another suspension procedure was described by BEYDEREV of the Centre for the Treatment of Incontinence, of Irvine University in California. This consists of a percutaneous procedure which makes it possible to capture with a threaded needle a maximum portion of the mobile part of the pubocervical fascia and of the tissues situated laterally and on both sides of the neck of the bladder and of the urethra, the suspension of the said neck being achieved by means of anchorage of the ends of the aforesaid lateral suspension threads on two points of the pubic bone. These suspension threads are tensioned and fastened in a first intervention to these anchorage points inserted into the bone. But it is clear that the initial tension imparted to the aforesaid suspension threads cannot be adjusted easily nor modified afterwards after time has lapsed since the urological intervention.
The great problem which arises in all the surgical procedures described is to know to what precise degree the neck of the bladder should be raised and positioned or the precise degree of compression of the urethra in order to guarantee the correction of the incontinence and to obtain normal micturition. Because if the surgeon exceeds it by raising the urethro-vesical union a few millimetres more or extensively compresses the urethra, a urinary obstruction will be produced, a frequent complication which renders repeated or permanent explorations necessary. On the other hand, if by default the surgeon falls short in the lifting or compression of the urethra, then the incontinence will soon reappear.
There is no test or proof available which makes it possible to know this, that is to say, there are no parameters for determining the appropriate degree of tension for the fixing of the sling. This crucial moment of fastening the two sutures which support and raise the neck of the bladder and the urethra depends on subjective appraisal or empirical determination on the part of the surgeon; it is more art than science. But even accepting that the appropriate point of elevation of the urethro-vesical union or that of compression of the urethra has been found, and the two objectives have been achieved, that of curing the incontinence and that of restoring normal micturition, it is not known for how long this situation will last or persist, since it is rarely permanent or definitive and this is because the correction mechanisms fail or because the tissues fail through the natural process of involution or ageing. The urethral closure pressure (sphincter) declines markedly with age, or in the course of life an illness may occur (bronchitis, asthma) which entails an increase in the intra-abdominal pressure which strains the containment system created and the incontinence reappears.
More recently, endeavouring to overcome this indeter-minate adjustment of the effect of suspension of the neck of the bladder, various mechanical adjustment procedures have been proposed. But these procedures require the establishment, during the intervention and on the abdomen of the patient, of mechanical adjustment means, either a single one located in the central part and on which the lateral suspension threads are joined, or by means of two lateral adjustment mechanisms generally formed, in both cases, by screw-threaded parts which can be adjusted manually from outside above the abdomen of the patient. These adjustment mechanisms remain on the one hand inside, and on the other hand outside the abdomen of the patient after the urological operation and for several days, with a risk of infection, until the adjustment operations are deemed to have been completed. Then, the said adjustment mechanisms have to be separated from the body and the retaining means or final anchorage of the ends of the said threads arranged, in order, finally, for the said open wounds at the anchorage points to be covered by the corres-ponding adipose tissue and the skin in order to cover up the incisions made, as well as the aforesaid fixed retain-ing means for the ends of the suspension threads.
It will be understood that after all these operations have been carried out, further mechanical adjustments will not be possible except by means of further surgical interventions.
But, in practice, further adjustments of the tension of the sling are always necessary, since the tensioning threads stretch in different proportions after the urological intervention or simply when the tissues suffer certain structural changes after a period of time.
This plethora of procedures described in the medical technical literature confirms the non-existence of ideal methods.
As already stated, the principal reason for the difficulties encountered for the suspension sling procedure is the impossibility of obtaining easy control of the tension of the suspension threads thereof.
According to what was published in the Journal of Urology (Vol. 14, January 1989), some doctors, researchers of the Nagoya University School Department of Urology, state that the tension of the threads of the sling has not been quantified either for the genuine incontinence stress or for the neurogenic bladder.
In spite of the popularity of the system of suspension of the neck of the bladder, no articles have appeared which have mentioned and quantitatively specified the degree of tension which should be imparted to the suspension threads of the sling at the moment when they are tied to a rela-tively fixed retaining part.
The stretching of the threads is generally understood to be between 4 and 8 per cent after a period of 70 days, depending on their initial tension.
The result of this ambiguity is frequently manifested in transitory or definitive retention or difficulty in urinating if the threads have been tied with too much tension at the end of the intervention, or in persistent incontinence if the opposite occurs.